FDA Details How Sponsors Should Make Expanded Access Policies Public and Available

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FDA Details How Sponsors Should Make Expanded Access Policies Public and Available

J.W. Schomisch

November 4, 2022 at 02:04 PM EST

Revised FDA draft guidance on expanded access explains how sponsors can meet new requirements of the 21st Century Cures Act and the FDA Reauthorization Act of 2017 (FDARA) requiring them to make their policies for evaluating and responding to expanded access requests public and readily available. The guidance, which updates guidance issued in 2017, also includes additional re... Read More

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FDA Details How Sponsors Should Make Expanded Access Policies Public and Available

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